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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER MODULE
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SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER MODULE Back to Search Results
Model Number 91496
Device Problem Defective Alarm (1014)
Patient Problem Bradycardia (1751)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
Spacelabs has initiated an investigation into this matter.A supplemental report will be filed once the investigation is complete.
 
Event Description
Spacelabs has received a report on (b)(6) 2019 that on (b)(6) 2019, that a bedside monitor failed to alarm for a "low rate" when the heart rate decreased to 40bpm.
 
Manufacturer Narrative
Findings from the historical data show that ecg and spo2 alarms were either disabled or alarm limits were set at values that prevented the system from triggering an alarm for this episode of bradycardia that did not meet the alarm criteria.All audio/audible alarm indicators operated according to specification when tested by a spacelabs field service engineer.There is no evidence of device malfunction.This investigation is considered complete and the matter closed.H3 other text : placeholder.
 
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Brand Name
SPACELABS ULTRAVIEW SL COMMAND MODULE
Type of Device
ULTRAVIEW SL MULTIPARAMETER MODULE
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
35301 se center st.
snoqualmie WA 98065
MDR Report Key9564859
MDR Text Key198594626
Report Number3010157426-2019-00043
Device Sequence Number1
Product Code DSI
Combination Product (y/n)Y
PMA/PMN Number
K103142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/01/2005,06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number91496
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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